Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin irritation / corrosion
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: 67/548 CEE
- Deviations:
- no
- GLP compliance:
- no
Test material
- Test material form:
- other: viscous liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing:iron stainless steel cage model 1472 "tecniplast"
- Diet : pellet, ad libitum
- Water : municipal filtered water, ad libitum
- Acclimation period:7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 ± 1 °C
- Humidity (%): 55 ± 15 %
- Air changes (per hr):8 per hour
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g - Duration of treatment / exposure:
- one application/ 4 hours
- Observation period:
- 24, 48, 72 hours , 5, and 7 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: ~ 10 cm^2
- Type of wrap if used: multiple foil surgical gauze (2.5 X 2.5 cm). The gauze is fixed by ipoallergenic adhesive bandage (Blenderm BM). The entire animal's trunk is protected by elastic bandage (Acrylastic Beyersdorf)
SCORING SYSTEM: according to OECD guideline 404
Erythema, Edema
Negative control: The surface near of a test application has been used as negative control
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1, 4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 3, 6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 2, 5
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 1, 5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 2, 4
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 3, 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
Any other information on results incl. tables
| erythema | check | 1 | 2 | 3 | 4 | 5 | 6 | mean |
| 24h | 1 | 2 | 2 | 1 | 2 | 2 | 1.66 | |
| 48h | 1 | 2 | 2 | 1 | 2 | 2 | 1.66 | |
| 72h | 1 | 1 | 2 | 1 | 1 | 2 | 1.33 | |
| 5d | 0 | 1 | 1 | 1 | 1 | 1 | 0.83 | |
| 7d | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| edema | check | 1 | 2 | 3 | 4 | 5 | 6 | mean |
| 24h | 1 | 1 | 0 | 1 | 1 | 0 | 0.66 | |
| 48h | 1 | 1 | 0 | 1 | 1 | 0 | 0.66 | |
| 72h | 1 | 0 | 0 | 0 | 1 | 0 | 0.33 | |
| 5d | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 7d | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as a skin irritant or skin corrosive according to the CLP Regulation (EC) No.1272/2008
- Conclusions:
- Based on results the test material does not presents any signs of irritation
- Executive summary:
The skin irritation/corrosion potential of the test item was evaluated in vivo. The substance was applied on the shaved skin of six Newzeland albino rabbit in an occlusive coverage.
The animals were observed for signs of erythema and edema at 24, 48, 72 hours, 5 and 7 days
Based on the scores of erythema and edema, the test material does not present any signs of irritation.
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